scholarly journals Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Josep Lluis Carbonell ◽  
Rita Acosta ◽  
Yasmirian Pérez ◽  
Roberto Garcés ◽  
Carlos Sánchez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Uterine Fibroids ◽  
Uterine Myoma ◽  
Similar Improvement ◽  
End Of Treatment ◽  
Fibroid Volume

Objectives. To evaluate the efficacy, safety, and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9-month followup period. Design. Randomized clinical trial. Place. “Eusebio Hernández” Hospital, Havana, Cuba. Subjects. 220 women with symptomatic uterine fibroids. Treatment. One-half (2.5 mg) or one-whole 5 mg mifepristone tablet. Variables to Evaluate Efficacy. Changes in fibroid and uterine volumes, in symptomatic prevalence and intensity, and in quality of life. Results. After 3-month treatment, fibroid volume decreased by 27.9% (CI 95% 20–35) and 45.5% (CI 95% 37–62), in the 2.5 and 5 mg groups, respectively, P=0.003. There was no difference in the prevalence of symptoms at the end of treatment, unlike after 6- and 9-month followup when there was a difference. Amenorrhea was significantly higher in the 5 mg group, P=0.001. There were no significant differences in mifepristone side effects between the groups. Both groups displayed a similar improvement in quality of life. Conclusions. The 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose. This trial is registered with ClinicalTrials.gov NCT01786226.

scholarly journals THE EFFECT OF TREATMENT WITH MIFEPRISTONE ON THE QUALITY OF LIFE OF PATIENTS WITH UTERINE MYOMA

2017 ◽  
pp. 136-141 ◽  
Author(s):  
S. A. Levakov ◽  
N. A. Sheshukova
Keyword(s):  
Quality Of Life ◽  
Uterine Fibroids ◽  
Uterine Myoma ◽  
Large Majority ◽  
Drug Induced ◽  
Sonographic Examination ◽  
End Of Treatment ◽  
Study Results ◽  
Reduction Of Pain

Purpose of the study: evaluation of the quality of life of patients with symptomatic uterine myoma up to 12 weeks of gestation against a background of mifepristone 50 mg daily continuously for 3 months.Material and methods. The prospective study involved 141 patients with uterine myoma who received treatment with mifepristone (Gynestril®) 50 mg continuously for 3 months. In order to evaluate changes in the volume of uterine bleeding, each patient kept a diary where she registered the number of sanitary napkins used. Sonographic examination was used to evaluate the size of the uterus and fibroids. The Visual Analogue Scale (10-point VAS scale) was used to assess the pain intensity. Quality of life of patients and their satisfaction with the therapy was also evaluated by a 10-point VAS scale. The complaints, physical examination data and results of sonographic studies were recorded before and immediately after the end of treatment (1st and 2nd visits).Study results. Drug therapy with Gynestril® (mifepristone 50 mg) for patients with uterine myoma for 3 months helped to obtain a statistically significant (p < 0.001) improvement across all the evaluated parameters: in a large majority of patients, control of menstrual blood loss was achieved (decreased duration and volume of bleeding), while 85 patients (60.3%) achieved reversible drug-induced amenorrhea, and 43 patients (30.5%) - oligomenorrhea; a large majority of patients achieved reduction of pain severity according to VAS, while in 118 (83.7%) patients the parameter was estimated as “slight pain/no pain” after the end of treatment. According to the ultrasound results, a statistically significant decrease was achieved in the number of displayable fibroids (from 2.1 to 1.9 at an average), the volume of the dominant myoma node (on average by 65% from 37.34 to 13.27 cm3) and of the uterus (an average of 35% from 182.71 to 118.09 cm3). In addition, a vast majority of patients - 99.9% - evaluated the quality of life and satisfaction with treatment as high.Conclusions. Therefore, the results of the study demonstrate that Gynestril® is highly effective, safe and promising in the pharmaceutical treatment of uterine fibroids. 

scholarly journals Telerehabilitation Intervention in Patients with COVID-19 after Hospital Discharge to Improve Functional Capacity and Quality of Life. Study Protocol for a Multicenter Randomized Clinical Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 2924
Author(s):  
José-Manuel Pastora-Bernal ◽  
María-José Estebanez-Pérez ◽  
Guadalupe Molina-Torres ◽  
Francisco-José García-López ◽  
Raquel Sobrino-Sánchez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Hospital Discharge ◽  
Study Protocol ◽  
Functional Capacity ◽  
Treatment Method ◽  
Current Evidence ◽  
Current Standard

COVID-19 can cause important sequels in the respiratory system and frequently presents loss of strength, dyspnea, polyneuropathies and multi-organic affectation. Physiotherapy interventions acquire a fundamental role in the recovery of the functions and the quality of life. Regarding the recovery phases after hospital discharge, the current evidence available is very preliminary. Telerehabilitation is presented as a promising complementary treatment method to standard physiotherapy. The main objective of this research is to evaluate the effectiveness of a personalized telerehabilitation intervention after discharge from hospital for the improvement of functional capacity and quality of life compared to a program of health education and/or care in a rehabilitation center. As secondary objectives, to identify the satisfaction and perception of patients with the telerehabilitation intervention and the presence of barriers to its implementation, as well as to evaluate the cost-effectiveness from the perspective of the health system. This study protocol will be carried out through a single blind multicenter randomized clinical trial in the south of Spain. We hypothesize that the implementation of a telerehabilitation program presents results not inferior to those obtained with the current standard intervention. If the hypothesis is confirmed, it would be an opportunity to define new policies and interventions to address this disease and its consequences. Trial registration NCT04742946.

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